Enamel Matrix Derivatives on Systemic Inflammation After Periodontal Therapy (PERIOEMD-2)

University of Pisa

Status: Completed

Conditions: Periodontal Diseases

Treatments: Procedure: Root Instrumentation; Device: EMD Application

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03544931

3649/15B

Details and patient eligibility

About

The aim of this study is to compare periodontal treatment with or without the adjunct of an enamel matrix derivative in terms of acute-phase responses in healthy patients.

Full description

Patients with periodontitis will be randomly allocated to two groups. In both groups, periodontal root instrumentation will be performed. In the test group, an additional flapless application of enamel matrix derivatives will be granted for sites with pockets deeper than 5 mm.

Systemic inflammation as measured through blood testing and local parameters of periodontal health will be measured at baseline and three months after treatment completion.

Enrollment: 38 patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Good health
• No previous periodontal treatment
• Presence of Periodontitis (Clinical attachment loss of at least 3 mm in 2 or more non-adjacent teeth)
• Ability to understand the study procedures and comply with them through the length of the study

Exclusion criteria

• Pregnancy and breast feeding
• Need for antibiotic treatment during periodontal therapy
• Chronic infections
• Systemic diseases
• Patients who report current smoking over 20 cigarettes per day

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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38 participants in 2 patient groups

Root Instrumentation + EMD Application

Experimental group

Description:

Periodontal treatment is delivered with ultrasonic instrumentation performed with fine tips. The approach chosen is the one-stage full-mouth ultrasonic debridement in which all the treatment of diseased sites is performed within one hour. In this group, at the end of the instrumentation enamel matrix derivatives is placed in all sites with a periodontal pocket depth deeper than 5mm.

Treatment:

Device: EMD Application

Procedure: Root Instrumentation

Root Instrumentation

Active Comparator group

Description:

Periodontal treatment is delivered with ultrasonic instrumentation performed with fine tips. The approach chosen is the one-stage full-mouth ultrasonic debridement in which all the treatment of diseased sites is performed within one hour.

Treatment:

Procedure: Root Instrumentation